A Phase 1 interventional study of Botulinum Toxin Type A (BOTOX) Injection in Oromandibular Dystonia and Electromyography, sponsored by Sana'a University. Completed at 1 site in Yemen. Open to participants aged 31 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Sana'a University · Phase 1, Interventional, and Treatment
This study evaluates the effectiveness and safety of Electromyography (EMG)-guided Botulinum Toxin type A (BTX-A) injections in treating oromandibular dystonia (OMD) among a sample of Yemeni patients. Oromandibular dystonia is a neurological movement disorder characterized by involuntary contractions of the jaw, tongue, and face muscles, which severely interferes with essential daily functions such as chewing, speaking, and swallowing.
A prospective clinical trial was conducted on 20 patients diagnosed with different clinical subtypes of OMD (jaw closing, jaw opening, and jaw deviation). Targeted muscles were injected with BTX-A using EMG guidance to ensure precise placement. Patients were evaluated over a 6-month follow-up period to measure improvements in mastication ability, speech, and functional discomfort, as well as to document any adverse side effects.
213 studies on the registry are indexed under Dystonia; 54 are open to participants now.
This study's enrollment of 20 is below the median of 28 across 114 interventional studies indexed under Dystonia.
Browse Dystonia studies →Sana'a University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
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i) Patients with a confirmed diagnosis of OMD based on clinical evaluation. ii) Patients who have been referred to the maxillofacial departments at the Faculty of Dentistry, Sana'a University, specifically for the treatment of OMD.
iii) Commitment to follow-up visits
Exclusion Criteria:
i) The presence of pathological findings at the site of injection, such as fibrous dysplasia, tumors, or cysts.
ii) Patients who have known or allergies to botulinum toxin or its components.
iii) Patients who are unlikely to be available for the required follow-up visits or have limited accessibility to the study site.
iv) Previously treated with BTX-A within 6 months. v) Pregnant woman.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Botulinum Toxin Type A (BOTOX) Injection
Drug: Botulinum Toxin Type A (BOTOX) Injection
Electromyography (EMG)-guided intramuscular injections into specific affected masticatory and lower facial muscles. Dosing is tailored to the specific oromandibular dystonia subtype (e.g., jaw closing, jaw opening, or mixed) and targeted muscles (such as the Masseter, Temporal, Medial Pterygoid, Lateral Pterygoid, or Digastric muscles). The injections are administered using an EMG device (e.g., Dantec Clavis) to ensure precise localization of the hyperactive muscles prior to injection.
Change in Oromandibular Dystonia Symptoms Following EMG-Guided Botulinum Toxin Type A Injection
The primary outcome was the change in the severity of the main symptoms of oromandibular dystonia following electromyography-guided botulinum toxin type A (BTX-A) injection. The symptoms assessed were mastication ability, discomfort, speech, and pain. Each symptom was evaluated using a 5-point ordinal rating scale ranging from 0 (normal/no symptoms) to 4 (severe impairment). Changes from baseline were assessed during follow-up visits at 1 week, 3 months, and 6 months after BTX-A injection.
Time frame: Baseline (immediately before BTX-A injection), 1 week, 3 months, and 6 months after injection
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A
Sana'a University